Associate Director, Site Start Up
Singapore, Singapore- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal
At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Organization (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.
Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.
At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.
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Job Description
Objective / Purpose:
- Responsible for line management of assigned Takeda Site Start Up staff, as well as defining, developing, and delivery of the global site start up project plan in APAC by partnering with the CRO and site start up team on site start up.
- Provide guidance to staff and oversee the analysis of clinical trial intelligence data in APAC region and its application to effectively conduct accurate and effective site start up forecasts, robust scenarios, and accurate planning.
- Directly support priority or highly complex projects through the site start up process.
- Champion the creation and implementation of innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued site start up services.
Accountabilities:
- Responsible for line management, mentoring, and development of assigned Takeda Site Start Up staff
- Responsible for oversight of project deliverables of FSP
- Accountable for defining, developing, and delivery of the Global Site Start Up Project Plan.
- Partners with CROs, Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes
- Provides guidance, oversight, and training to the Site Start Up team, delivering activities in support of Clinical Programs, including data and methodologies for protocol site start up, site start up planning, and modeling
- Ensures consistent standards are applied to the site start up process across project portfolios and supports continuous improvement activities while developing and implementing TA-aligned strategies / approaches
- Drives the creation and implementation of innovative solutions to improve processes and accelerate site start up timelines
- Leverages leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting
- Agrees to deliverables on a country and site-level basis with the CRO and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.
- Leads the cross-functional site activation team - internal plus CRO, utilizing the appropriate team members to support the implementation of the Start up Project Plan
- Serves as point of escalation and assist in resolution of issues identified by Takeda or CRO staff during the start up process
- Act as a role model for Takeda’s values
Education & Competencies:
- BS degree or international equivalent in a life science required, advanced degree preferred
- Extensive experience (≥ 8 years) in Clinical Operations, Project Management, site start up, and / or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor required
- More than 5 years of direct responsibility in site management, activation and oversight of the site start up processes of clinical research studies at a sponsor or CRO
- Expertise in clinical trial regulations and ethics committee submissions across APAC region
- Experience in line management and working in a matrix environment
- Expertise with leading edge trial optimization vendors, tools, and methods
- Proficiency with software models and database structures
- Expertise in principles driving site start up and site start up strategies
- Direct experience in the pharmaceutical industry or related field required
- Ability to strongly demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning
- Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team
- Ability to explain data, facilitate decision making processes to be data driven
Locations
Singapore, SingaporeWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere you fit in
As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.
We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.
Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.
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Advance clinical research
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Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity
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Enable end-to-end management of clinical supply
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Ensure safety management and inspection readiness
One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.
Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office
It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.
Penny Carlson - Head, Global Clinical Development Operations
The heart of our work
Shining a light on new perspectives
Our pipeline
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
What we believe in
Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
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Integrity
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Fairness
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Honesty
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Perseverance
Working at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Great Place to Work
Recognized for our culture and ways of working, we’re proud to be Certified as a Great Place to Work® in 25 countries and regions. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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